Regional
Obstacles are opportunities in disguise – the therapeutic plasma exchange experience
Tanya Glatt
South African National Blood Service, South Africa
Thabo Gcayiya
South African National Blood Service, South Africa
Yona Skosana
South African National Blood Service, South Africa
Hans Vreilink
Sanquin Blood Supply Foundation, Netherlands
Riana Cockeran
South African National Blood Service, South Africa
The South African National Blood Service (SANBS) provides a mobile apheresis service in 8 of 9 provinces in South Africa. We perform approximately 2000 clinical apheresis procedures a year of which ~68% are therapeutic plasma exchange (TPE) procedures.
In line with current ASFA guidelines 1 our standard practice is to use fresh frozen plasma (FFP) and 4% human albumin solution as replacement fluid for the treatment of haematological and neurological conditions respectively. The FFP is sourced from SANBS, while the 4% human albumin is sourced from a single supplier in South Africa.
The different neurological conditions that require TPE as a treatment modality (Figure 1) include Neuromyelitis Optica (NMO) accounting for over half the total procedures (51%), followed by Myasthenia Gravis (16%) and Guillain-Barre Syndrome (GBS) (13%). The use of TPE for neurology patients is the fastest growing area of our clinical apheresis program, resulting in the use of over 4000 bottles of 4% human albumin in the first six months of 2024. The sustainable supply of and access to replacement fluid, such as 4% human albumin, is a necessity to meet our patients’ needs.
Figure 1: Indications for therapeutic plasma exchange procedures performed at SANBS for neurological conditions (January 2023-December 2023)
In September 2024 there was a national shortage of human albumin which presented a major obstacle in servicing these patients. In an attempt to ensure the continuation of our patients’ treatment, an alternative to human albumin was sought. The use of Gelofusine (a synthetic colloid available in 30g/L and 40g/L formulations) as a volume replacement in therapeutic apheresis is increasing internationally 2, 3. The benefits of using Gelofusine include increased availability and accessibility, decreased price and longer shelf life when compared to human albumin.
In addition, Gelofusine is not human-derived and therefore lacks the theoretical risk of transmission of infectious diseases and is acceptable to Jehovah’s Witness patients. The risk of hypocalcaemia secondary to ACD may be less significant/common when Gelofusine is used as opposed to human albumin as the latter is known to potentiate the effects of ACD. Currently, in South Africa, Gelofusine is 75% cheaper than 4% human albumin solution, and available from multiple suppliers.
Per 100ml, locally available Gelofusine contains 4g succinylated gelatin, 0.7g sodium chloride, 0.14g sodium hydroxide, 15.4mmol of sodium and 15mmol of chloride. Locally available 4% human albumin solution comprises of protein 4g/100ml (with at least 95% human albumin), dextrose 3g/100ml, sodium < 130mmol/l, potassium <2 mmol/l and citrate <4 mmol/l. The standard practice in clinical apheresis is to provide 100% fluid balance. Gelofusine, similar to 4% human albumin solution, is slightly hypotonic when compared to plasma, therefore a fluid balance of 110% may be used to decrease the risk of hypovolaemia. The use of Gelofusine as a replacement fluid in TPE for neurological procedures was validated in our facility.
Seven procedures were performed on five patients with the diagnosis of NMO. All procedures were well tolerated without any adverse events, hypovolaemia, hypotension, allergic reactions or symptomatic hypocalcaemia; with a total blood volume processed of 1.1. There were no clinically significant decreases in blood pressure and in 71% (5/7) of the procedures, the blood pressure was the same or higher post-procedure compared to pre-procedure. Clinical aspects of TPE procedures using Gelofusine continue to be monitored and reported in our facility.
A shortage of our standard replacement fluid required us to validate a new replacement fluid in our clinical apheresis setting. This new replacement fluid offers improved cost, availability and access to patients with specific religious requirements, which is important in a resource-restricted and culturally diverse setting such as South Africa. Although Gelofusine performed well in our validation, there was apprehensiveness from clinicians who are not familiar with its use in this setting.
In addition, the omission of it in the ASFA guidelines adds to this uncertainty.
A sustainable and safe apheresis service does not only require the availability of instrumentation and skilled personnel but also the availability of consumables and reagents. Therefore, all critical items should be sourced from more than one supplier and validated alternatives identified. Clinical apheresis services in our country are limited by access and affordability; to improve access to patients, cost-saving measures should be explored.
